Kornimate/medical-research-clean huggingface dataset:
acp-204 in adults with alzheimer's disease psychosis open label extension study

Conditions: Alzheimer's Disease Psychosis

Summary: this 52-week, open-label extension study is to evaluate the long-term safety and tolerability of acp-204 in subjects with adp.


Eligibility criteria:
inclusion criteria: * subject has successfully completed acp-204-006 study * male or female (age 55 to 95 years old): female must be of non-childbearing potential, male must take appropriate contraceptive method if partner has childbearing potential * subject has a designated study partner/caregiver * subjects are able to complete all study visits with a study partner/caregiver * signed inform consent form with a caregiver or legal representative exclusion criteria: * requires treatment with a medication prohibited by the protocol * is in hospice and receiving end-of-life palliative care, or has become bedridden * female who is pregnant or breastfeeding * unstable clinically significant medical condition other than ad * any medical condition that in the opinion of the investigator may affect safety or ability to complete the study additional inclusion/exclusion criteria apply. subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Keywords: alzheimer's disease psychosis hallucinations delusions
efficacy of the movincog intervention in children

Conditions: Learning Disorders; Learning Disabilities; Cognitive Change

Summary: this study aims to test the efficacy of the movincog intervention to enhance cognitive abilities in children 7-15 yrs. the intervention consists of two parts: a physical exercise regimen, based on high-intensity training, and a cognitive training component. the design will contrast the intervention with an active control group, matched for expectancy effects.

specifically, the investigators will compare both components together (exercise and cognitive training) against either one of the components (exercise alone, or cognitive training alone) and against an active control group. the study will include measures of scholastic aptitude, as well as of working memory and cognitive control (primary outcome measures), two cognitive abilities that are critical to daily life activities, and that respond well to training. in addition, the investigators will measure physiological responses to training, to monitor changes associated with exercise (secondary outcome measures). finally, the investigators will relate training-specific improvements with transfer gains, to better model the interaction between training and transfer. this will provide a comprehensive understanding of the dynamics associated with the intervention.

Eligibility criteria:
inclusion criteria: * age 7-15 exclusion criteria: * age outside inclusion criteria * history of seizures, brain trauma

Keywords: cognitive training physical exercise brain dynamics cognitive abilities physiological markers
foot core training in individuals with pes planus

Conditions: Pes Planus

Summary: foot core training is very important for the intrinsic muscles of the foot, but it is often neglected in exercise programs given to individuals with pes planus. the aim of our study is to reveal the effects of foot core training, which will be added to the exercise program routinely given to individuals with asymptomatic flexible pes planus, on walking, muscular activations, balance and lower extremity functional performance with objective, evidence based results.

this study is a randomized controlled study and will be carried out on volunteer individuals with asymptomatic flexible pes planus aged between 18-25, studying at alanya alaaddin keykubat university. persons meeting the inclusion criteria will be determined by the specialist physiotherapist. surface electromyography (semg) measurements will be made by a doctorate physiotherapist. other evaluations will be made by a specialist physiotherapist. individuals who meet the inclusion criteria, who volunteered to participate in the study and signed the consent sheet will be randomly divided into two groups, the control group and the foot core group. individuals with initial evaluations will be followed up in an exercise program planned for 8 weeks. the control group will be given exercises to strengthen the weakened muscles, stretch the shortened structures and increase proprioception. foot core training will be given to the study group in addition to the exercises given to the control group. before and after exercise, the subjects will be assessed with navicular height measurement, muscle activation evaluation, evaluation of walking parameters, functional lower extremity performance evaluation and balance evaluation.

Eligibility criteria:
inclusion criteria: * individuals who volunteer to participate in the study * individuals between the ages of 18-25 * individuals with a body mass index between 18.5-30. * individuals with a difference of 10 mm or more between weighted and unweighted measurements by applying the navicular drop test * individuals who are considered to have flexible pes planus with a positive jack's finger lift test exclusion criteria: * individuals with symptoms such as any pain in the foot and ankle, fatigue. * individuals with any neurological or orthopedic disease affecting the lower extremity. * individuals with a history of foot-ankle trauma-surgery * individuals with lower extremity inequality of more than 1 centimeter (cm)

Keywords: pes planus electromyography gait balance
the role of central sensitization in pain, functionality, and quality of life in cancer patients

Conditions: Central Sensitization

Summary: pain is one of the most important and challenging symptoms in cancer patients. depending on the stage of cancer, approximately 40% to 70% of patients complain of pain. with the increasing lifespan of cancer patients due to developing treatments, pain palliation has become even more crucial to improve their quality of life. cancer-related pain can develop through multiple mechanisms such as the tumor itself, metastasis, or the methods used in treatment. the type of pain can be nociceptive, neuropathic, or mixed. central sensitization refers to the increased response of central nervous system nociceptive neurons to normal or subthreshold stimuli. recently, central sensitization (cs) has been recognized as a potential pathophysiological mechanism underlying a group of chronic pain diseases such as fibromyalgia, temporomandibular joint disorder, irritable bowel syndrome, interstitial cystitis, tension-type headache, and chronic low back pain. since pain perception varies from person to person, physicians should assess the character of pain thoroughly and not rely solely on peripheral pain treatment in cases with a component of central sensitization. the lack of evaluation of the extent to which central sensitization affects patients and the failure to fully determine the factors influencing it appear to be clinical limitations for now. there are studies suggesting that central sensitization may be a significant factor in chronic refractory pain in cancer patients, indicating the need for consideration of alternative options to classical treatments. to the best of our knowledge, no study has been conducted in turkey to investigate the frequency of central sensitization and its impact on treatment outcomes in chronic cancer pain patients visiting outpatient clinics. the aim of this study is to investigate the frequency of central sensitization and its effect on pain and quality of life in chronic cancer pain patients attending algology clinics in multiple centers in turkey.


Eligibility criteria:
inclusion criteria: * aged between 18 and 80 years 1. diagnosis of cancer confirmed pathologically 2. experiencing cancer or cancer treatment-related pain complaints for more than 3 months exclusion criteria: * 1.patients with chronic pain not related to cancer will be excluded from the study 2.patients who do not provide consent to participate in the study 3.patients with conditions such as dementia, traumatic brain injury, advanced psychiatric disorders (schizophrenia, etc.), chromosomal disorders (down syndrome), genetic diseases (fragile x syndrome), and neurodegenerative diseases that may lead to mental disorders.

Keywords: central sensitization cancer patients
healthy opportunities for physical activity and nutrition (hop'n) after-school project

Conditions: Obesity Prevention

Summary: this study presents evaluates the effectiveness of the healthy opportunities for physical activity(hop'n) after-school program on preventing obesity in children. the investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the hop'n program. the investigators also hypothesized that after-school intervention hop'n sites will increase in physical activity and healthful eating opportunities compared to control sites.

the dramatic increase in the prevalence of overweight among children and adolescents has led to obesity prevention becoming a major national health priority. although schools offer a logical choice for a setting to reach a great number of youth, these disappointing findings may be due in part to the difficulties of implementing interventions in school settings where competing demands for time have made it difficult to add anything other than academics to the school day. after-school programs may provide promise for preventing child obesity because there are fewer bureaucratic obstacles and curricular inflexibilities. a three-year group-randomized controlled trial will be conducted with random assignment at the school level . the study will use a nested cross section design with a baseline year, and two subsequent intervention years.

Eligibility criteria:
inclusion criteria: * after-school program participant in fourth grade group * informed parental consent * assent to participate in body mass index assessment exclusion criteria: * third or fourth grade student * participant in study in previous year

Keywords: obesity prevention after-school physical activity fruit vegetable children
implementation of supportive sling device in adults post-stroke for prevention of shoulder complications

Conditions: Cerebrovascular Accident

Summary: upper limb (ul) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function.

upper limb (ul) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function. pain associated with ul impairment due to multifactorial causes is a frequent symptom in patients with stroke. occupational therapy techniques focus on the implementation of positioning techniques and the use of supportive devices (sd) such as slings aimed to prevent pain; therefore increase daily function, participation and hence quality of life. at present, positioning principles of the hemiplegic shoulder exist in clinical practice. these are aimed at prevention of pain associated with ul impairment; however there is no clear consensus among professionals of particular sd that should be implemented for adults with stroke

Eligibility criteria:
inclusion criteria: * having suffered in the last 6 months maximum a first stroke responsible for hemiplegia. * finding a clinical 5mm appendix, or with shoulder pain requiring prescription a scarf. * boston diagnostic aphasia examination (bdae) \> 3. * consent of the patient * patient affiliated or benefiting from a social security scheme exclusion criteria: * stroke recurrence, or stroke more than 6 months-old * patient already wearing a coaptation scarf * presence of lymphoedema, venous thrombosis of the upper limb * neoprene allergy * severe cognitive impairment: mini-mental state (mms) \<15 * patient being part of another care protocol * adult under the protection of justice, tutors or curators * pregnant or lactating woman.

Keywords: cerebrovascular accident sling upper limb impairment
effects of fish oil in alleviating health hazards associated with ozone exposure

Conditions: Cardiovascular System; Respiratory System; Oxidative Stress; Inflammation

Summary: this study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary effects induced by ozone exposure.

the investigators will conduct a randomized controlled trial among 64 healthy young adults in shanghai, china. the eligible participants will be randomly assigned in a 2\*2 factorial design to 1 of 4 groups: 1) fish oil and ozone exposure, 2) fish oil and shame exposure, 3) soy oil and ozone exposure, or 4) soy oil and shame exposure. the participants who take fish oil would receive 2.2 g/day (two 1.1-g capsules daily) in divided doses, and other participants will take the same amount of soy oil capsules. two hour ozone exposure (200 ppb ozone) or shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation. ozone is generated by a silent electric discharge method (htu-500, azco industries ltd., canada) and introduced into the chamber. the temperature and relative humidity in the chamber are maintained at 22±1℃ and 50%±5%, respectively. during the 2-hour exposure, each subject alternate 15 minutes of exercise on a treadmill and 15 minutes of rest. the exercise workload would be adjusted to achieve the targeted ventilation of 20±1 l/min/m2 body surface area. health examinations will be conducted immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning.

Eligibility criteria:
inclusion criteria: * living in shanghai during study period; * ability to complete the training exercise to induce an inspired ventilation rate of 20±1 l/min/m2 body surface area; * body mass index \>18.5 and ≤30 (30 is the lower limit for class 2 obesity for chinese); * taking the fish oil or placebo on time. exclusion criteria: * being allergic to seafood; * smoking and alcohol abuse; * current drug and dietary supplements intake; * subjects with allergic disease, such as allergic rhinitis, allergic asthma, and atopy; * subjects with cardiovascular disease, such as congenital heart disease, pulmonary heart disease, and hypertension; * subjects with respiratory disease, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease; * subjects with chronic disease, such as diabetes, chronic hepatitis, and kidney disease; * subjects with a history of major surgery; * abnormal spirometry (fev1 and fvc ≤ 75% of predicted and fev1/fvc ≤ 0.65); * abnormal baseline 12-lead resting electrocardiogram; * abnormal blood index, such as cell counting, blood lipids, and glutamic-pyruvic transaminase (gpt).

Keywords: ozone exposure fish oil 2*2 factorial design
high-resolution imaging of tear film thickness in contact lenses wearers with optical coherence tomography (oct). a pilot study

Conditions: Contact Lens; Tear Film Thickness

Summary: a refractive error is the most common reason for reduced visual acuity. myopia, hyperopia, astigmatism and presbyopia belong to the four basic refractive errors and, unfortunately, cannot be prevented. there are different tools to correct them, like spectacles, contact lenses, and refractive surgery. many different contact lenses are available, the two large groups create rigid contact lenses and soft contact lenses. it is a common knowledge that the presence of a contact lens in the eye divides the tear film into the prelens and postlens tear film layers. in the present study we want to investigate the variability and reproducibility of prelens and postlens tear film thickness measurements.


Eligibility criteria:
inclusion criteria * men and women aged over 18 years * soft or rigid contact lenses wearers * schirmer test ≥ 10 mm/5 min * tear breakup time (tbut) ≥10 seconds exclusion criteria: * participation in a clinical trial in the previous 3 weeks * presence of any abnormalities preventing reliable measurements as judged by the investigator * pregnancy, planned pregnancy or lactating
tislelizumab with azacitidine in the treatment of r/r aml

Conditions: Refractory AML; Relapsed Adult AML

Summary: acute myeloid leukemia(aml) is a clonal hematological malignancy. 50%-90% adult aml patients can achieve complete remission(cr) after standard induction chemotherapy,but 10%-25% patients cannot achieve cr, which is called 'primary refractory disease'.most of patients who achieved cr will relapse during the next 3 years, and the prognosis is poor.so refractory and relapse diseases are still the hotspot of clinical research.immunologic escape is one of the mechanisms for tumor cells to survive from chemotherapy. studies have shown that pd1 and pdl1 levels are upregulated in aml patients, the same phenomenon was observed after the treatment of demethylating agents such as azacytidine. combination of pd1 blockades with azacytidine may improve the efficacy of the treatment.

in this phase 1/2 study, 20 patients will be enrolled and treated with azacytidine and tislelizumab regimen. the primary endpoint is composite complete remission rate.toxicities of treatment need to be observed. and relationship between pdl1 expression on aml cells and efficacy will be studied. treatments include azacytidine 75mg/m2/d, subcutaneous injection,day1-7, every 28 days for three cycles tislelizumab 200mg,day 8,every three weeks, for 4 doses.

Eligibility criteria:
inclusion criteria: * diagnosis of aml according to fab or who criteria * refractory or morphological relapsed aml * age over 18 years old * ecog ps 0-2 * written informed consent exclusion criteria: * acute promyelocyte leukemia * solitary extramedullary relapsed disease * other hematological diseases * antecedent stem cell transplantation * aml with bcr_abl positive * acute panmyelosis with myelofibrosis or sarcoma * with other active organ malignancy(needing treatment) * active heart diseases * unfit for enrollment after investigator's evaluation
enhanced mirror therapy for improving brain reorganization and function in stroke

Conditions: Stroke

Summary: this research aims to test the methodological procedures and obtain preliminary results regarding the therapeutic and cost-effectiveness of enhanced mirror therapy relative to standard mirror therapy for improving brain reorganization and upper limb function in individuals with stroke.

stroke is among the leading causes of mortality and disability, worldwide. muscle weakness and other complications associated with stroke can result in decreased quality of life and significant declines in the activities of daily living. mirror therapy has been shown to have a moderate effect, facilitating the functional recovery among individuals who have experienced a stroke. a prototype for a computerized, mirror therapy device was developed and found to be feasible. recently, the investigators published a critical review and an activation likelihood estimation (ale) meta-analysis analysing the widespread reports of brain activity associated with mirror therapy. observations using functional near-infrared spectroscopy (fnirs) to evaluate a group of people with stroke (n = 14) and healthy volunteers (n = 18) revealed that performing complex tasks during the mirror therapy paradigm enhanced top-down motor facilitation in the ipsilesional/ipsilateral hemisphere relative to the moving limb. an important next step in this series of studies is to evaluate the training effects associated with the performance of complex tasks during mirror therapy among stroke patients, using the designed computerized mirror therapy device to deliver the enhanced mirror therapy training. the results of this study will help the investigators to understand the underlying mechanisms through which mirror therapy facilitates motor rehabilitation and will add to the body of literature describing the best, evidence-based practices for mirror therapy during stroke rehabilitation. the investigators propose a pilot study (n = 30) to test the methodological procedures and obtain preliminary results for a fully powered, randomized, controlled trial (rct), combined with economic evaluation, to compare the therapeutic and cost-effectiveness between standard mirror therapy and enhanced (complex task and blurred image) mirror therapy.

Eligibility criteria:
inclusion criteria: * adults with stroke (40-75 years old), with normal or corrected-to-normal vision and hearing; * post-stroke duration of ≥ 6 months, before the start of data collection; * no severe deficits in memory, communication, or the ability to understand verbal instructions. exclusion criteria: * participants with recurrent stroke; and * those who score \< 24 on the mini-mental state examination (mmse).

Keywords: mirror therapy stroke hand function cost-effectiveness
neuroplasticity with daily use of a sensorimotor priming vibration system to improve hand function after stroke

Conditions: Stroke; Physical Disability

Summary: more than 4 million stroke survivors in the u.s. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. hand disability has a profound negative impact on functional ability and independence. one way to improve hand function is to use peripheral sensory stimulation. sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. while promising, most modalities of sensory stimulation interfere with natural hand tasks. to address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. in this study, we will determine if use of this vibration increases hand functional recovery.

the study design is a double-blinded randomized controlled study. subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. follow-up evaluation will occur 3 months after. the device will deliver vibration (treatment) or no vibration (control).

Eligibility criteria:
inclusion criteria: * chronic stroke survivor (\>= 6 months post stroke) * ability to move an object with the paretic hand * fingertip sensory deficits * ability to put on a watch daily (by oneself or with help) exclusion criteria: * currently undergoing other upper extremity rehabilitation therapy * upper limb botulinum toxin within 3 months prior to or during enrollment * change in neurological disorder medications during the enrollment * complete upper limb deafferentation * rigidity (modified ashworth scale=5) * brainstem stroke * comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners) * language barrier or cognitive impairment that precludes following instructions and/or providing consent if a participant has contraindications for transcranial magnetic stimulation (tms), the participant will not do tms.

Keywords: physical stimulation subliminal stimulation stroke rehabilitation upper extremity paresis hand function occupational therapy physical therapy